Surgical tattooing apparatus and method

ABSTRACT

Instrumentation and a method for facilitating surgical tattooing in connection with radiation thereby incorporating a novel ink dispensing instrument having sterile tattoo ink. The dispensing instrument is connectable to a surgical tattoo needle to ensure the delivery of sterile ink during each procedure. Subsequent to demarcation, the instrument and needle may be discarded.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to a surgical apparatus and methodfor tattooing a patient for a surgical procedure, and, more particularlyto a universal procedure and associated instrumentation for tattooingradiation patients for purposes of identifying target points forrepetitive radiation.

[0002] Tattooing in a hospital setting must be sterile. Any injectionreceived in a hospital setting should be as clean as possible to reducepatient harm. Current methods for patient demarcation or tattooing inconjunction with radiation therapy utilize unsterile modalities forapplying the ink for the tattoo. In a typical procedure, the ink isprovided in a common inkwell which is subject to a number ofcontaminants during use. Specifically, the inkwell becomes contaminatedonce it is opened. Thereafter, the repetitive insertion of tattooingneedles/syringes on multiple patients introduces additional contaminantswhich, may additionally increase the potential for transmission ofinfectious diseases between subsequent patients.

SUMMARY OF THE INVENTION

[0003] Accordingly, the present invention is directed to a new standardprocedure or protocol, and associated instrumentation, for applying asurgical tattoo. In a preferred embodiment, a method for surgicallytattooing a patient, comprises the steps of providing a sealed inkdispensing instrument having sterilized tattoo ink therein and defininga port for dispensing said tattoo ink, dispensing the tattoo ink fromthe port of the ink cartridge, directing the tattoo ink with respect topredetermined body tissue of a patient to mark the body tissue anddisposing the ink cartridge after use on the patient. The ink dispensinginstrument may have a deformable ink cartridge with the tattoo inktherein whereby the step of dispensing includes deforming the inkcartridge to dispense the tattoo ink under pressure. A needle may beconnected to the ink cartridge adjacent the port such that the tattooink is passed through a lumen in the needle to mark the predeterminedbody tissue.

[0004] A surgical ink dispensing instrument for facilitating surgicaltattooing of a patient is also disclosed. The dispensing instrumentincludes an ink cartridge defining an internal chamber, and having aport in communication with the internal chamber and sterile tattoo inkdisposed within the internal chamber of the ink cartridge. The inkcartridge may be substantially flexible to permit the operator to deformthe ink cartridge to expel the tattoo ink through the port. An end capis removably mounted to the ink cartridge about the port tosubstantially enclose the port. The ink cartridge may define a generallyelongated portion for engagement by the user.

[0005] The method and instrumentation of the present invention ensuresthe use of sterile tattoo ink in each tattooing procedure therebyovercoming disadvantages of current practices used for surgicaltattooing.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] Preferred embodiments of the present invention will be betterunderstood with reference to the drawings wherein:

[0007] FIGS. 1-2 are frontal and rear perspective views of an inkdispensing instrument for use in accordance with the principals of thepresent invention;

[0008]FIG. 3 is a perspective view with parts separate of the dispensinginstrument of FIG. 1;

[0009]FIG. 4 is a cross-sectional view of the dispensing instrument;

[0010]FIG. 5 is a perspective view of an alternate embodiment of the inkdispensing instrument of FIG. 1;

[0011]FIG. 6 is a cross-sectional view of the dispensing instrument ofFIG. 5;

[0012]FIG. 7 is a side cross-sectional view of the dispensinginstrument;

[0013]FIG. 8 is a perspective view of another alternate embodiment ofthe ink dispensing instrument of FIG. 1;

[0014]FIG. 9 is a cross-sectional view of the dispensing instrument ofFIG. 8;

[0015]FIG. 10 is a perspective view with parts separated of thedispensing instrument;

[0016]FIG. 11 is a side cross-sectional view of the dispensinginstrument; and,

[0017]FIG. 12 is a flow chart illustrating the preferred procedure forapplying a surgical tattoo with the instrumentation.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The preferred embodiment of the method and instrumentationdisclosed herein are discussed in conjunction with a surgical tattooingprocedure for radiation therapy. It is envisioned, however, that theinvention may be applicable to a variety of procedures including,non-surgical tattooing procedures.

[0019] The following discussion includes a description of theinstrumentation utilized in applying a surgical tattoo followed by adescription of the preferred method or protocol utilizing theinstrumentation

[0020] Referring now to the drawings wherein like reference numeralsidentify similar like elements throughout the several views, FIGS. 1-4illustrate a preferred ink dispensing instrument in accordance with thepresent invention. Tattoo ink dispensing instrument 10 includesessentially three elements, namely, ink cartridge 12, leading cap 14 andtrailing cap 16. Ink cartridge 12 defines internal cavity 18 whichaccommodates the sterile ink. Ink cartridge 12 has a generallyfrustoconical outer shape or configuration with an enlarged trailing end20 which gradually tapers to a smaller leading end 22. Leading end 22defines a narrowed distribution port 24 which has an internal lumen 26communicating with the internal cavity 18 of ink cartridge 12.

[0021] Trailing end 20 of ink cartridge 12 includes a circumferentialcollar 28 to which trailing cap 16 is mounted. In the preferredembodiment, trailing cap 16 includes a transverse outer wall 30 which isjoined to circumferential collar 28 of ink cartridge by conventionalmeans, including for example adhesives, cements, snap fit threadedmeans. In the preferred embodiment, trailing cap 16 is joined to the inkcartridge 12 through an ultrasonic welding technique. Trailing cap 16preferably defines internal circumferential stop 32 which is receivedwithin the trailing end 20 of the ink cartridge in sealing engagementtherewith.

[0022] Trailing end cap 16 defines an elongated length which facilitatesfunctioning of the trailing end cap 16 as a handle. Preferably, in usethe operator holds end cap 16 in a manner similar to that of a writingimplement thus providing ease of control and a degree of familiarity tothe operator.

[0023] Leading cap 14 is placed on ink cartridge 12 prior to loading ofthe ink and preferably includes an internal stop 34 which is receivedwithin the lumen 26 of the port 24 to fluidly seal the port 24 at thisend. Leading cap 14 further defines an internal circumferential wall 36which is mounted about the port 24 and preferably dimensioned so as tofrictionally engage the port 24 to thereby retain the end cap 14 on theink cartridge during assembly and shipping.

[0024] As best depicted in FIG. 4, the tattoo ink 38 (represented as- - - ) filled within ink cartridge 12 is and is FD&C approved steriletattoo ink which is the only ink permitted for human skin tattooing.Various colors are contemplated.

[0025] The components of the instrument 10 are preferably fabricatedfrom a suitable polymeric material by known injection moldingtechniques. Ink cartridge 12 may have some rigidity to minimizedeformation thereof whereby the tattoo ink is gravity fed throughdistribution port 24. Alternatively, ink cartridge 12 may be flexible tobe squeezed in a manner to force the tattoo ink through distributionport 24. Trailing end cap 16 is preferably rigid.

[0026] The preferred dimensions of the instrument are as follows:

[0027] l₁—length of trailing end cap: 2-3 inches, preferably about 2.5inches

[0028] l₂—length of cartridge: 1.5-2.1 inches, preferably about 1.8inches

[0029] d₁—diameter of trailing end cap: 0.250-0.450 inches, preferablyabout 0.350 inches.

[0030] In a preferred method of manufacture, leading cap 14 is mountedto ink cartridge 12 and the ink cartridge 12 is filled with sterile FD&Capproved tattoo ink. Thereafter, trailing cap 16 is then mounted to inkcartridge 12 and sealed through the ultrasonic well joint. Thus theentire device is hermetically sealed, sterile and filled with theappropriate FD&C approved tattoo ink. This device can be prepackaged andshipped and delivered to the end user.

[0031] The ink dispensing instruments of the afore-described embodimentsare intended for use in conjunction with a tattoo needle 38 depicted inFIG. 3 which may be secured to the device through any number of knownconventional means. For example, the needle 38 can be mounted about thedistal port and connected therewith with threaded means (shown inphantom) on the needle 38 as internal threads 39 which threadably engagecorresponding threads (not shown) of cartridge 12, a bayonet coupling, africtional engagement, etc. Alternatively, the needle is not requiredand the ink from the ink cartridge can be dispensed onto a needle pointwhich is subsequently applied to the skin of the patient for tattooing.

[0032] FIGS. 5-7 illustrate an alternate embodiment of the dispensinginstrument of FIG. 1. In this embodiment, the trailing cap iseliminated. Ink cartridge 12 has an elongated portion or handle 40adjacent its trailing end and integrally forward therewith duringinjection molding. The handle includes recessed grooves 42 (bestdepicted in FIG. 6) which accommodate the fingers of the user. Theelongated portion on handle 40 enables the operator to hold theinstrument in a manner similar to using a pencil or pen. This providesthe user with a familiar feel that enhances control when applying thetattoo. This instrument defines a length ranging from 4.00-4.50 inches,preferably about 4.25 inches.

[0033] FIGS, 8-11 illustrate another embodiment of the presentinvention. The device in these figures is substantially similar to theprior embodiment and includes an ink cartridge 60 defining a generallybulbous shape which is rounded at its proximal end. The distal end ofthe ink cartridge 60 includes a distal port 62 and has a end cap 64which is mounted to the distal port in the manner discussed above. Theink cartridge 60 may comprise two components, namely, the ink basecartridge 66 and a nozzle 68 which defines the distal port 62 and isultrasonically welded to the base 66 to connect the two components. Thebulbous ink cartridge 60 facilitates holding of the instrument betweenthe index and middle finger, and the thumb and provides a greater areato facilitate squeezing or deformation of the ink cartridge to expel thesterile tattoo ink.

[0034] Surgical Tattooing Protocol

[0035] The preferred surgical tattooing protocol with theinstrumentation will now be discussed with reference to the flow chartof FIG. 12. In step 100, the prepackaged ink dispensing instrument isprovided and opened by tattooing personnel. A sterilized tattooingneedle 38 is mounted to ink cartridge 16 as discussed hereinabove.Alternatively, if desired, a mounted tattooing needle is not utilized.The needle is then introduced to the skin of the patient. With referenceto steps 200, 300, the ink cartridge is dispensed (step 200) or squeezed(or if gravity fed no squeezing is required) to deliver the ink throughdistal port into the needle and then directed (step 300) into the skinof the patient. After use, the needle and ink cartridge are discarded(step 400). In an alternate arrangement, a tattooing needle is notmounted to the ink cartridge, but, is introduced within the skin.Thereafter, the tattoo ink is applied to the outer surface of the needleto travel along the needle into the tissue.

[0036] It is contemplated that the dispensing instrument of the presentinvention will be individually wrapped in a sterile packet attached andboxed. The packets will be attached to each other and an operator wouldpull off one packet at a time when needed. See, e.g., the dispensingsystem disclosed in U.S. Pat. Nos. 5,358,140 and 5,282,349, the contentsof each being incorporated herein by reference. The novel instrumentswill be used for safe and sterile application of permanent tattoo dotson skin for purposes of identifying points of interest. The predominantuse would be on radiation patients although other uses are envisioned aswell.

[0037] The present apparatus will lower medical wastes in department. Inaccordance with the present invention, the instrument is preloaded withpermanent or semi-permanent ink dye. The preloaded instrument would beused to penetrate the skin at predetermined locations and thereafteractivated to deliver the ink dye to appropriately tattoo the patientfor, e.g., successive radiation treatments. After use, the instrumentwould be disposed although it is envisioned that the syringe could besterilized for subsequent use(s).

[0038] The present invention thus contemplates the aforediscussedsurgical tattooing apparatus and a method for tattooing a patientutilizing the apparatus. The system assures that sterile tattoo ink isused for each individual patient.

[0039] While the above description contains many specifics, thesespecifics should not be construed as limitations on the scope of thedisclosure, but merely as exemplifications of preferred embodimentsthereof. Those skilled in the art will envision many other possiblevariations that are within the scope and spirit of the invention

What is claimed is:
 1. A method for surgically tattooing a patient,comprising the steps of: providing a sealed ink dispensing instrumenthaving sterilized tattoo ink therein and defining a port for dispensingsaid tattoo ink; dispensing the tattoo ink from the port of the inkcartridge; directing the tattoo ink with respect to predetermined bodytissue of a patient to mark the body tissue; and disposing the inkcartridge after use on the patient.
 2. The method according to claim 1wherein the ink dispensing instrument includes a deformable inkcartridge having said tattoo ink therein and wherein said step ofdispensing includes deforming said ink cartridge to dispense said tattooink under pressure.
 3. The method according to claim 2 further includingthe step of connecting a needle to said ink cartridge adjacent said portand wherein said step of directing includes passing said tattoo inkthrough a lumen in said needle to mark the predetermined body tissue. 4.The method according to claim 3 wherein said step of directing includespenetrating the predetermined body tissue with said tattoo needle. 5.The method according to claim 1 wherein said step of directing includespenetrating the predetermined body tissue with a tattoo needle andapplying said tattoo ink to said tattoo needle.
 6. The method accordingto claim 1 wherein said ink dispensing instrument includes an inkcartridge having an internal cavity for accommodating said tattoo ink.7. A surgical ink dispensing instrument for facilitating surgicaltattooing of a patient, which comprises: an ink cartridge defining aninternal chamber, said ink cartridge defining a port in communicationwith said internal chamber; and sterile tattoo ink disposed within saidink cartridge.
 8. The device according to claim 7 wherein said inkcartridge is substantially flexible to permit the operator to deformsaid ink cartridge to expel said tattoo ink through said port.
 9. Theapparatus according to claim 8 further including an end cap removablymounted to said ink cartridge about said port to substantially enclosesaid port.
 10. The device of claim 6 wherein said ink cartridge definesa generally elongated portion for engagement by the user.